Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079183
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2004-03-08
Brief Title:
Sirolimus as Secondary Therapy in Chronic Graft-Versus-Host Disease Not Responding To Prior Treatment
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Sirolimus for Secondary Treatment of Chronic Graft-versus-Host Disease
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the side effects and how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease GVHD that did not respond to prior treatment Sirolimus may be an effective treatment for chronic GVHD
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety of sirolimus administered at a dose which provides steady-state whole blood trough levels of 5-10 ngmL in patients with chronic GVHD
II To determine whether administration of sirolimus provides benefit for patients with chronic GVHD that has not responded adequately to previous systemic treatment
OUTLINE
Patients receive sirolimus orally PO once daily QD Patients continue to receive prednisone and cyclosporine or tacrolimus at the discretion of the managing physician
After completion of study treatment patients are followed up periodically
I To assess the safety of sirolimus administered at a dose which provides steady-state whole blood trough levels of 5-10 ngmL in patients with chronic GVHD
II To determine whether administration of sirolimus provides benefit for patients with chronic GVHD that has not responded adequately to previous systemic treatment
OUTLINE
Patients receive sirolimus orally PO once daily QD Patients continue to receive prednisone and cyclosporine or tacrolimus at the discretion of the managing physician
After completion of study treatment patients are followed up periodically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-01817 | REGISTRY | CTRP Clinical Trial Reporting Program | None |